GlaxoSmithKline Begins Distribution of Flu Vaccine to U.S. Customers for 2010-2011 Flu Season

PHILADELPHIA, July 30 /PRNewswire-FirstCall/ -- GlaxoSmithKline (NYSE: GSK) announced today that the U.S. Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER) has released the first lots of FluLaval® [Influenza Virus Vaccine] allowing distribution in the U.S. to begin for the 2010-2011 flu season. GSK anticipates distribution of Fluarix® [Influenza Virus Vaccine] to follow in the next several weeks.

GSK expects to supply more than 30 million doses combined of FLULAVAL and FLUARIX this flu season. FLULAVAL is approved for use in adults (18 years of age and older) to help protect against influenza disease. FLUARIX is approved for use in adults and children (3 years of age and older).

Earlier this year, vaccine experts at the Centers for Disease Control and Prevention (CDC) recommended that individuals six months and older should get a flu vaccine each year. The 2010-2011 flu vaccine will offer protection against the 2009 H1N1 pandemic virus and two other flu viruses.

"The spread of seasonal flu remains an important public health issue and takes the lives of approximately 36,000 people each year," said Peter Lammers, Vice President, U.S. Vaccines, GlaxoSmithKline. "GSK is proud to provide millions of doses of flu vaccine in preparation for this year's flu season and in support of the government's goal to expand flu vaccination."

About Flu

The flu, or influenza, is primarily passed from one person to another through the air by droplets released when an infected individual coughs or sneezes, but may also be spread by direct contact with flu virus-contaminated surfaces.  

According to the CDC, annual flu vaccination is the most effective method for preventing flu virus infection and its complications. CDC's Advisory Committee on Immunization Practices (ACIP) voted for "universal" flu vaccination in the U.S. to expand protection against the flu to more people.

The beginning, severity and length of the flu season can vary widely from year to year. While influenza outbreaks can happen as early as October, most of the time influenza activity peaks in January or later. In general, healthcare providers should begin offering vaccination soon after the vaccine becomes available. The CDC recommends that individuals receive their flu vaccinations as soon as it is available from their healthcare provider.

Important Safety Information for FLUARIX

• Do not administer FLUARIX to anyone with known systemic hypersensitivity reactions to egg proteins (a vaccine component) or a life-threatening reaction to previous administration of any influenza vaccine
• If FLUARIX is administered to immune-suppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immune-competent persons
• If Guillain-Barre syndrome has occurred within six weeks of receipt of prior influenza vaccine, the decision to give FLUARIX should be based on careful consideration of the potential benefits and risks
• The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals
• In clinical trials with FLUARIX, the most common adverse events in adults included injection site pain and redness, muscle aches, fatigue and headache. Most adverse events in adult clinical trials were mild and self-limited. In children 5 years to <18 years of age, the most common adverse events were similar to those in adults but also included injection site swelling. In children 3 years to <5 years of age, the most common adverse events included pain, redness, and swelling at the injection site, irritability, drowsiness, loss of appetite and fever. (See adverse reactions section of the Prescribing Information for FLUARIX for other potential adverse events)
• Vaccination with FLUARIX may not protect 100% of susceptible individuals

Important Safety Information for FLULAVAL

• FLULAVAL should not be administered to anyone with known systemic hypersensitivity reactions to eggs, egg products, egg or chicken proteins, or any component of FLULAVAL
• FLULAVAL should not be administered to anyone who has had a life-threatening reaction to previous administration of any influenza vaccine
• If Guillain-Barre syndrome has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLULAVAL should be based on careful consideration of the potential benefits and risks
• In comparator-controlled clinical trials with FLULAVAL, adverse events included pain and redness at the injection site, muscle aches and fatigue. Most adverse events in clinical trials were mild and self-limited  (See adverse reactions section of the Prescribing Information for FLULAVAL for other potential adverse events)
• Vaccination with FLULAVAL may not protect 100% of susceptible individuals

GlaxoSmithKline: A Leader in Influenza Vaccine Manufacturing

GlaxoSmithKline has an active research and development program targeted at both seasonal and pandemic flu and has recently invested more than $2 billion to expand capacity for manufacturing its flu vaccines FLUARIX and FLULAVAL and its antiviral flu medication RELENZA® (Zanamivir).  

GlaxoSmithKline: A Leader in Vaccines

GlaxoSmithKline Biologicals (GSK Biologicals), GlaxoSmithKline's vaccines business, is one of the world's leading vaccine companies and a leader in innovation. The company is active in the fields of vaccine research, development and production with over 30 vaccines approved for marketing and 20 more in development.

GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information go to us.gsk.com, follow us on twitter.com/GSKUS or visit our blog (www.morethanmedicine.us.gsk.com/blog/).

Cautionary statement regarding forward-looking statements

Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company's Annual Report on Form 20-F for 2009.

SOURCE GlaxoSmithKline